NCT00943904|CompletedResultsDMC
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Sponsor study identifier
interventional
31
1 country
1
Study Start
July 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2012
Actual (reported)Study Completion
February 2012
Actual (reported)Sacral nerve stimulation (SNS) implantation is a minimally invasive procedure which has current FDA approval for urinary urge incontinence, urgency-frequency syndrome and non-obstructive urinary retention, and has been available in the United States since 1997. The SNS delivers non-painful, mild electrical pulses to the sacral nerves to modulate the reflexes that influence the bladder, sphincter, and pelvic floor to improve or restore normal voiding function. While SNS has been shown to have efficacy for the aforementioned conditions, the exact mechanism of action is unknown, but it is believed to work primarily through the somatic afferent system in promoting inhibitory reflex pathways to facilitate urine storage. The degree of stimulation is thought to be at a level that only evokes a sensory and not a motor response; however this has not been tested.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2009
Date type not reportedThis date has not been verified as actual or estimated.
July 20, 2009
Actual (reported)July 22, 2009
Actual (reported)February 2012
Actual (reported)February 2012
Actual (reported)October 6, 2021
Actual (reported)Percent of Symptoms With Improvement of Leaks Reported
Percent change in improvement of symptoms after reprogramming in terms of number of leaks reported. Nocturia refers to leaks that happened while asleep. Incontinence refers to both stress and urge leaks. Urgency refers to only urge leaks. Positive values represent more improvement of symptoms and therefore less leaks. Negative values represent less improvement and therefore more leaks.
6 months following enrollment
Patients who receive the interstim implant in order to evaluate effectiveness of treatment
stimulates third sacral nerve root
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
UCI Women's Healthcare
Orange, California, 92868, United States
Karen Noblett, MD
University of California, Irvine
31 participants (actual enrollment reported by the registry).
First Submitted
July 20, 2009
First Posted
July 22, 2009
Study Start
July 2009
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
February 2012
Actual (reported)Study Completion
February 2012
Actual (reported)Last Updated
October 6, 2021
Results First Posted
October 6, 2021
Record last verified: 2021-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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